FYC

Product Code: FYC


Products Classified as FYC

2817Gown, Isolation, SurgicalSurgical Apparel.

Total Product Life Cycle (TPLC) Devices

2817Gown, Isolation, SurgicalSurgical Apparel.

FDA Consensus Standards

Gown, Isolation, Surgical [32348]21 CFR §878.4040 🔎
Gown, Isolation, Surgical [36974]21 CFR §878.4040 🔎
Gown, Isolation, Surgical [32435]21 CFR §878.4040 🔎

Pre-market Notifications for FYC

K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd
K220528Surgical Isolation Cover GownWuhan Dymex Healthcare Co., Ltd.
K214116AAMI4 Isolation GownHubei Xinxin Non-woven Co.,Ltd.
K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC
K212698Plus Medical Isolation Gown Level 3Foshan Nanhai Plus Medical Co Ltd
K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, BlueString King Lacrosse, LLC
K212504Isolation Gown AAMI Level 3Kenpax International Limited
K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty.Ltd.
K212357Surgical Isolation GownWuhan Zonsen Medical Products Co., Ltd
K211538Protect X Level 3 Isolation GownAZAC Group
K210785Disposable Surgical GownsChongqing Litai Fashion Group Limited Company
K210414CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4036YKTP-L4, CoverU Disposable Gown With Tape AAMI Level 4 Isolation Gown, Model Number: IL-4063WKTP-L4, CoverU Disposable Gown With Tape Chemo Gown, Model Number: IL-4036Medtecs (Taiwan) Corp.
K210148Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reFlomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
K210131ComfortGuard Surgical Isolation GownGRI-Alleset, Inc
K203415Surgical Isolation GownYanbian Pacific Textile Co., LTD

Global Unique Device Identification Database

20813360023046Gown, Isolation, Surgical
00812564039491Gown, Isolation, Surgical
00812564039323Gown, Isolation, Surgical
00812564035981Gown, Isolation, Surgical
00812564033420Gown, Isolation, Surgical
00812564033413Gown, Isolation, Surgical
00812564033383Gown, Isolation, Surgical
00812564032713Gown, Isolation, Surgical
00812564032195Gown, Isolation, Surgical
00812564032034Gown, Isolation, Surgical
00812564031945Gown, Isolation, Surgical
00812564031938Gown, Isolation, Surgical
00812564031921Gown, Isolation, Surgical
10818566010930Gown, Isolation, Surgical
10818566010923Gown, Isolation, Surgical

Maude Adverse Events

HALYARDO&M HALYARD, INC.2019-09-18
ACMF CARDIO PACK BLUE 2KIMBERLY-CLARK HEALTH CARE2014-07-11
COVER GOWN, YELLOWCARDINAL HEALTH2014-03-10
*GOWN, ISOLATIONKIMBERLY CLARK2013-07-16
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-25
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY CLARK2013-04-11
UNKPERSONAL PROTECTION GOWNBUSSE HOSPITAL DISPOSABLES2013-03-18
ISOLATION GOWNKIMBERLY-CLARK2013-03-05
ISOLATION GOWNKIMBERLY-CLARK CORPORATION2012-12-18
CONVERTORS YELLOW IMPERVIOUS ISOLATION GOWN W/KNIT CUFF, FULL BACK, UNIVERSALCARDINAL HEALTH2010-05-12
IMPERV. ISOLATION GOWN W/THUMBHOOKS 30/CCARDINAL HEALTH2008-12-11
GOWN ISOLATION YELLOWCARDINAL HEALTH2007-04-11
GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL,CARDINAL HEALTH2006-05-03
GOWN ISOLATION YELLOWCARDINAL HEALTH2004-10-15
ISOLATION GOWN W/THUMB LOOP*1997-07-28
MELCO ISOLATION GOWNSMELCO INC.1995-07-31
ISOLATION GOWNMELCO, INC.1995-05-18
GOWNSAFETEC OF AMERICAL, INC.1994-03-21
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